Analyte meter protectors and methods

ABSTRACT

Analyte meter protectors, meters that include the same, and methods.

This application claims priority to U.S. Provisional Application Ser.No. 60/871,910 that was filed with the United States Patent andTrademark Office on Dec. 26, 2006. The entire disclosure of U.S.Provisional Application Ser. No. 60/871,910 is incorporated byreference.

BACKGROUND OF THE INVENTION

Analytical testers, also sometimes referred to as sensors, are commonlyused to monitor the level of an analyte in a body fluid. For example,diabetics use analyte testers to monitor body glucose levels.

Analyte testing may involve testing once per day, but typically shouldbe carried out periodically throughout the day using multiple analytetesters—one tester for each test. To “read” a tester, i.e., to analyzethe body fluid applied to a tester and determine one or more analytelevels, a tester reader, oftentimes referred to as a “meter”, is used.Either before or after a sample of body fluid is applied to a tester,the tester is received by the meter. The meter performs variousfunctions and analyzes the tester-applied sample to provide an analytelevel to the user.

The tester receiving area of a meter, commonly referred to as a tester“port”, is the opening in a meter that receives a tester for testing.The tester port is therefore an opening from the outside meterenvironment to the interior of the meter. Because the interior isexposed to the outside environment via the tester port, the potentialfor contaminating materials to enter the meter's interior through theport exists. For example, unintended fluid ingress into the port fromblood, interstitial fluid, control solution, cleaning fluid, or otherfluids may occur. This unintended fluid ingress may interfere with thereadings and confound the analyte results. Given the importance ofobtaining accurate analyte level readings, it is imperative that themeter does not become contaminated.

Accordingly, as meters continue to be used for analyte monitoring, therecontinues to be an interest in analyte monitoring devices that areprotected from contamination. Of interest are port protectors that areeasily removable and replaceable, e.g., disposable.

SUMMARY OF THE INVENTION

Analyte testing medical devices, and components for use with the same,as well as methods of using the medical devices and components foranalyte testing are provided.

Various embodiments include a meter port protector attachable to an areaof a meter tester port. In many embodiments, a protector is disposable,e.g., easily removable and attachable.

In certain embodiments, a protector includes a slot for receiving ananalyte tester. The slot may be dimensioned to provide minimal clearancebetween a surface of the slot and a surface of a received tester. Forexample, in certain embodiments a protector slot may be dimensioned toswipe or squeegee across a fluid-containing surface of a receivedtester. This may be useful to prevent unwanted fluid from entering thetester port of the meter and/or to meter the sample.

In many embodiments, the area defined by the opening of a protector isless than the area defined by the port of a meter. In this manner, thesize of the opening to the meter is reduced by the protector.

Embodiments also include self aligning protectors. These protectorsinclude features that correctly position the protectors withcorresponding meters.

Also provided are analyte meters that include a tester port. Embodimentsinclude meters having port protector removably secured about the ports.In certain embodiments, the protectors include a slot for receiving atester.

Also included are methods, where embodiments include attaching, e.g.,permanently or temporarily, a port protector about a port area of ameter. In certain embodiments, the methods include attaching a protectorto a meter to reduce the size of the area defined by the meter port.Embodiments also include removing a first port protector from a meterand attaching a second protector to the meter. This may be particularlyuseful in hospital or analogous settings in which a single meter may beused to read a plurality of testers, at least some of which may betesting sample from different individuals.

Various methods may be employed to connect a protector to meter. Suchmethods include removable connecting a protector to a meter, e.g., usingan adhesive, releasable tabs, etc.

Also provided are systems and kits that include an analyte meter and/orport protector and/or analyte tester, and/or lancing device. In certainembodiments, a plurality of protectors may be provided to a user, e.g.,bundled together such as in a kit.

These and various other features which characterize the invention arepointed out with particularity in the attached claims. For a betterunderstanding of the testers of the invention, their advantages, theiruse and objectives obtained by their use, reference may be made to thedrawings and to the accompanying description, in which there isillustrated and described various embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring now to the drawings, wherein like reference numerals andletters indicate corresponding structure throughout the several views:

FIG. 1 is an isometric front view of an exemplary embodiment of ananalyte meter;

FIG. 2A is an isometric front view of an exemplary embodiment of a portprotector; FIGS. 2B and 2C are isometric rear views of the protector ofFIG. 2A, and

FIG. 3 is an isometric front view of the meter of FIG. 1 with theprotector of FIGS. 2A-2C installed thereon.

DETAILED DESCRIPTION

As summarized above, protectors positionable about a tester opening orport of an analyte monitoring device are provided. The protectors aredesigned to mate with meters and more specifically mate with port areas.The protectors are particularly useful in preventing contaminants fromentering the meters through the tester ports.

The protectors may be adapted to be used with any medical device havingan opening and are particularly useful as adapted to be used with ananalyte monitoring medical device having an opening for receiving atester (also referred to as a test strip or sensor), such as an in vitroanalyte monitoring meter or in vivo analyte monitoring system, e.g.,those provided by Abbott Diabetes Care Inc. of Alameda, Calif.

Port-containing meters may be electrochemical or optical meters, and maybe configured to determine the level of one or more analytes, whereanalytes include, but are not limited to, glucose, blood β-ketone,ketone bodies, lactate, acetyl choline, amylase, bilirubin, cholesterol,chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones,lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroidstimulating hormone, and troponin, in sample of body fluid. Meters mayalso be configured to determined the concentration of drugs, such as,for example, antibiotics (e.g., gentamicin, vancomycin, and the like),digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may alsobe determined and the like, in a sample of body fluid. In certainembodiments, the protectors are shaped and sized to cooperate with aFreeStyle® brand blood glucose monitoring meter or a Precision® M brandblood monitoring meter capable of monitoring glucose and ketones, orother such analyte meters. The protectors may find use in metersdesigned for use in a hospital or similar clinic environment where asingle meter may be used for a plurality of patients. Such systemsinclude, but are not limited to, Precision PCx meters and FreeStyleConnect meters and Precision Xceed Pro manufactured by Abbott DiabetesCare.

In certain embodiments, the protectors may be configured to mate with aport of a continuous analyte monitoring system. For example, acontinuous glucose monitoring system may include a component thatreceives analyte data from a transcutaneously positioned or whollyimplanted inserted glucose sensor, and which component may be configuredto communicate analyte results to the user, e.g., audibly by way of adisplay, or visually. The continuous monitoring system receiver mayinclude a conventional blood glucose meter and therefore a port foraccepting a glucose tester. For example, an analyte meter may beincorporated into a module of a continuous analyte monitoring system,e.g., a transmitter module, receiver module, etc. Such may be convenientfor calibrating and/or confirming the continuous system. Theconventional meter and test strip may be used to calibrate thecontinuous system (see for example U.S. Pat. No. 6,175,752), e.g., usingone point calibration or other calibration protocol. It is to beunderstood that meters includes stand-alone meters, as well thoseoperably connected to, e.g., integrated with) continuous analytemonitoring systems. Exemplary testers and meters and continuous analytemonitoring systems (sometimes referred to as in vivo system) includetesters and meters such as those described, e.g., in U.S. Pat. Nos.6,071,391; 6,120,676; 6,143,164; 6,299,757; 6,338,790; 6,377,894;6,600,997; 6,773,671; 6,514,460; 6,592,745; 5,628,890; 5,820,551;6,736,957; 4,545,382; 4,711,245; 5,509,410; 6,540,891; 6,730,200;6,764,581; 6,299,757; 6,338,790; 6,461,496; 6,503,381; 6,591,125;6,616,819; 6,618,934; 6,676,816; 6,749,740; 6,893,545; 6,942,518;6,175,752; and 6,514,718, and elsewhere. In certain embodiments, theport may be included in, e.g., integrated, a drug delivery system, e.g.,in an insulin pump module such a pump or controller module thereof.

In certain embodiments, ports may include a tester slot. A slot is apassage through the body of the protector. Such a slot is dimensioned toadmit an analyte tester. As such, certain embodiments include slots thatare alignable with a meter port when the protector is connected to themeter. In this manner, when a protector is positioned about a meterport, a tester may be easily passed through the protector slot and intothe port.

The slots may be any suitable dimension. In certain embodiments, a slotmay be sized and shaped to provide minimal clearance between at leastone surface of the slot and at lest one surface of a received tester.For example, clearance may be one the order of millimeters, e.g., lessthan about 2.5 mm, e.g., less than about 1 mm. In certain embodiments atleast one surface of a protector slot may be configured to contact atleast one surface of tester, e.g., to swipe or squeegee across afluid-containing surface of a received tester. This may be useful toprevent unwanted fluid from entering the tester port of the meter and/orto meter the sample.

In many embodiments, the area defined by the opening of a protector isless than the area defined by the port of a meter. In this manner, thesize of the opening to the meter is reduced by the protector. Forexample, in certain embodiments, the area defined by a slot of aprotector may be less than 100% of the area defined by a port of a meterto which it is attachable, e.g., the area defined by a slot of aprotector may be less than 100% of the area defined by a port of ameter, e.g., may be less than 80% of area defined by a port of a meter.

The slots may be any suitable shape. The shape may depend at least inpart on the shape of the tester the meter is designed to accept. Incertain embodiments, the slots may be substantially rectangular, e.g.,in instances in which a substantially rectangular tester is employed.Other slot shapes may of course be used as well.

In certain embodiments, the slot may include a flexible valve that isdisposed at least partially across the slot, and in some embodimentscompletely across the slot. The flexible valve may include self-sealingslit(s) which open to permit a tester therethrough in response toincreased pressure on the slits, e.g., by a tester being pushed thereagainst.

In many embodiments, the protectors do not apply pressure to a testerreceived in the slot of the protector.

Port protectors may be fixedly attached/attachable to a meter, or may bewholly removable from a meter. For example, a protector may beattachable to a meter over the port, but yet easily removable by a userwhen access to the tester port is desired and/or when replacement withanother protector is desired. One or more engagement features may beused. An engagement feature(s) may be positioned on a protector and/or ameter. In certain embodiments adhesive is employed on a meter-contactingsurface of a protector. The adhesive may be any suitable adhesive, suchas contact adhesives, pressure sensitive adhesives, glues, epoxies,adhesive resins, and the like. In certain embodiments, the adhesive isapplied to a membrane of suitable thickness, e.g. foam. The adhesive maybe covered by a removable release liner to protect the adhesive from theenvironment until use. The release liner may be any convenient material,where representative release films include polyesters, such as PET orPP, and the like.

In certain embodiments molded features may be used. Such features mayhelp to attach a protector to a meter and/or align a protector with themeter, e.g., particularly for embodiments that include a slot. Moldedfeatures may be used to align the protector slot with the port so that atester may pass through the slot and into the port. For example, arib(s) or tab(s) may be used. One or more ribs (on a protector and/ormeter) may cooperate with a mating feature. Embodiments also includeprotectors configured to snap fit and/or friction fit with a meter. Incertain embodiments, a meter-contacting surface of a protector may havea form that corresponds to a meter's surface, e.g., may be a negative ofa meter surface. In certain embodiments, a portion of a protector may befixedly attached to a meter, allowing the unattached portion to moveaway from the meter. This may be useful for cleaning the protector. Incertain embodiments, the interface of a coupled meter and protectorprovides a substantially fluid tight seal.

In certain embodiments, a protector may also be configured to guide atester into a port. For example, a protector having a slot may includeguides, rails, channels, indentions, recessed structures, elevatedstructures, clamps, or the like, about the slot. Certain embodimentsinclude a ledge. The ledge may be an extension of a slot, e.g., a bottomof a slot may include ledge. It will be appreciated that words such as“top”, “bottom”, “upper”, and “lower”, and the like, are used in arelative sense only. In certain embodiments, a protector may includespaced apart guides. With this or analogous configurations, a tester maybe slid into position along the guides. The guides may be dimensionedsuch that a tester is snugly fit between the guides when it is mountedbetween the guides. During positioning of the tester, portions of thetester may be gripped (such as with a user's fingers) and the grippedportions used to then slide the tester into the mounted position betweenthe guides.

The protectors may be made of any suitable material and may besubstantially rigid or substantially flexible. In certain embodiments,the material is substantially flexible. Elastomeric materials may beused, e.g., rubber, or other compliant material. For example, foam maybe used. In certain embodiments, the material may be a thermoplasticelastomer (TPE), thermoplastic urethane (TPU), polycarbonate (PC),acrylonitrile butadiene-styrene (ABS) or a combination of two or threeof these. In certain embodiments, a protector has a hard plastic frame(e.g., PC-ABS) with a compliant area around the port opening.

Referring now to the Figures, FIG. 1 shows an isometric front view of anexemplary embodiment of an analyte meter 10. Meter 10 includes housing12 defining an interior space and having a tester port 14 for receivinga tester. An exemplary analyte tester 20 is shown positioned in port 14to be read by the meter. Analyte tester 20, e.g., a glucose tester, isshown as having a generally rectangular shape, but it is understood thatany shaped tester may be used. Analyte tester 20 can be any testersuitable for use with meter 10. Examples of testers 20 are disclosed,for example, in U.S. Pat. Nos. 6,299,757, 6,591,125, and 6,616,819. Thetester may have a sample chamber volume, for receive of sample (e.g.,blood) to be tested, of no more than about 1 microliter, and in someembodiments, a volume of no more than about 0.5 microliter or even nomore than 0.2 microliter.

This particular meter embodiment of FIG. 1 includes engagement detents16. Detents 16 are configured to retain a port protector.

FIG. 2A shows an isometric front view of an exemplary embodiment of aport protector 30. Protector 30 includes a body 31. Within body 31 isformed slot 32. While the embodiment of FIG. 2A includes a slot, asnoted above, certain embodiments do not include slots. In thoseembodiments that do not include a slot, the protector may be formed as aplug that cooperates with the port.

Protector 30 also includes tester positioning feature(s), in thisembodiment in the form of guide grooves 33 positioned on opposing sidesof the protector and a ledge or “diving board” feature 34.

Protector 30 also includes attachment features. FIGS. 2B and 2C showisometric rear views of protector 30 showing engagement ribs 35.Attachment features 35 in this embodiment are in the form of engagementprotrusions that extend outwardly from the protector. In certainembodiments the form of engagement may be indentations extendinginwardly into the protector. Attachment features also serve to align theprotector with the meter.

Engagement ribs 35 mate with detents on a meter, to hold the protectorin place on the meter. Some or all of the back surface of protector 35shown in FIGS. 2B and 2C may include adhesive thereon. Adhesive may bein addition to or in place of engagement ribs 35.

FIG. 3 shows an isometric front view of meter 10 with protector 30installed thereon. As shown, the protector narrows the opening to theinterior of the meter.

To perform an analyte test, a sample of biological fluid is provided tothe tester for analyte testing, where the level of analyte isdetermined. Sample may be applied to the tester before or after thetester is positioned in the meter. In many embodiments, it is the levelof glucose in blood, interstitial fluid, and the like, that isdetermined. Also in many embodiments, the source of the biological fluidis a drop of blood drawn from a patient, e.g., after piercing thepatient's skin with a lancing device or the like.

The invention has been described with reference to various specific andpreferred embodiments and techniques. However, it will be apparent toone of ordinarily skill in the art that many variations andmodifications may be made while remaining within the spirit and scope ofthe invention.

All patents and other references in this specification are indicative ofthe level of ordinary skill in the art to which this invention pertains.All patents and patent applications are herein incorporated by referenceto the same extent as if each individual patent was specifically andindividually incorporated by reference.

1-29. (canceled)
 30. An analyte meter, the meter comprising: a housingcomprising an interior space in communication with the outsideenvironment of the meter through an opening in the housing; a componentcomprising an opening and attached to the housing about the housingopening to prevent contaminants from entering the interior of thehousing while allowing an in vitro analyte test strip to contact themeter through the opening of the component.
 31. The meter of claim 30,wherein the component provides a substantially fluid tight seal with thehousing.
 32. The meter of claim 30, wherein the component comprises anelastomeric material.
 33. The meter of claim 32, wherein the componentcomprises rubber.
 34. The meter of claim 32, wherein the componentcomprises adhesive.
 35. The meter of claim 30, wherein the opening ofthe component comprises an in vitro analyte test strip guide.
 36. Themeter of claim 35, wherein the guide comprises a ledge.
 37. The meter ofclaim 30, wherein the meter is configured to be used with an in vitroanalyte test strip that is configured to test for analyte in a sample ofno more than about 1 microliter.
 38. The meter of claim 30, wherein theanalyte test strip is configured to test for analyte in a sample of nomore than about 0.5 microliter.
 39. The meter of claim 30, wherein theanalyte test strip is configured to test for analyte in a sample of nomore than about 0.2 microliter.
 40. The meter of claim 30, wherein themeter is a glucose meter.
 41. The meter of claim 30, wherein the meteris a ketone meter.
 42. The meter of claim 30, wherein the componentreduces the size of the opening of the housing when attached to thehousing.
 43. The meter of claim 30, wherein the meter is integrated withan in vivo analyte monitoring device.
 44. The meter of claim 43, whereinthe in vivo analyte monitoring device is a transmitter module.
 45. Themeter of claim 43, wherein the in vivo analyte monitoring device is areceiver module.